Generated Narrative: StructureDefinition m11-report-section-10
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Composition | 0..* | EvidenceReport | A set of resources composed into a single coherent clinical statement with clinical attestation | |
  type | ||||
 coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
 system | 1..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: 35528-9 | |
 display | 1..1 | string | Representation defined by the system Fixed Value: Clinical trial protocol Clinical trial protocol | |
| text | 0..1 | string | Plain text representation of the concept Required Pattern: CeSHarP Report | |
 Slices for category | 0..* | CodeableConcept | Categorization of Composition Slice: Unordered, Open by value:text | |
  category:statistics | 0..1 | CodeableConcept | Categorization of Composition | |
  coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
 system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218625 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS | |
 text | 1..1 | string | Plain text representation of the concept Required Pattern: section10-statistics | |
| Slices for section | 1..1 | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code.text | |
| section:statistics | S | 1..1 | BackboneElement | Composition is broken into sections |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Statistical Considerations | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218625 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10-statistics | |
| text | 0..1 | Narrative | Text summary of the section, for human interpretation | |
| Slices for section | 6..* | Nested Section Slice: Unordered, Open by value:code.text | ||
 section:considerations | S | 1..1 | BackboneElement | Nested Section |
 title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: General Considerations | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218626 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.1 General Considerations | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.1-general-considerations | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:analysisSets | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Analysis Sets | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218627 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.2 Analysis Sets | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.2-analysis-sets | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:analysisBaseline | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218628 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.3-analyses-demographics | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:analysisPrimaryObjective | S | 1..* | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218629 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: section10.4-analysis-primary-objective | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4-analysis-primary-objective | |
| text | 0..1 | Narrative | Text summary of the section, for human interpretation | |
| Slices for section | 1..* | Nested Section Slice: Unordered, Open by value:code.text | ||
| section:analysisPrimaryInstance | S | 1..* | BackboneElement | Nested Section |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218630 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1 Primary Objective | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1-analysis-primary-objective-instance | |
 focus | 0..1 | Reference(VariableDefinition) | Who/what the section is about, when it is not about the subject of composition | |
| text | 0..1 | Narrative | Text summary of the section, for human interpretation | |
| Slices for section | 3..* | Nested Section Slice: Unordered, Open by value:code.text | ||
| section:statisticalModel | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218631 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1.1-statistical-method | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| entry | 0..* | Reference(EndpointAnalysisPlan) | A reference to data that supports this section | |
| section:intercurrentEventHandling | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218632 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1.2-data-handling | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:missingData | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218633 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1.3-missing-data-handling | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:sensitvityAnalysis | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218634 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1.4-sensitivity-analysis | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| entry | 0..* | Reference(EndpointAnalysisPlan) | A reference to data that supports this section | |
| section:supplementaryAnalysis | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218635 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.4.1.5-supplementary-analysis | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:secondaryAnalysis | S | 0..* | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218636 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5-analysis-secondary-objective | |
| text | 0..1 | Narrative | Text summary of the section, for human interpretation | |
| Slices for section | 1..* | Nested Section Slice: Unordered, Open by value:code.text | ||
| section:analysisSecondaryInstance | S | 1..* | BackboneElement | Nested Section |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218637 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1 Secondary Objective | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1-analysis-secondary-objective-instance | |
| focus | 0..1 | Reference(VariableDefinition) | Who/what the section is about, when it is not about the subject of composition | |
| text | 0..1 | Narrative | Text summary of the section, for human interpretation | |
| Slices for section | 0..* | Nested Section Slice: Unordered, Open by value:code.text | ||
| section:statisticalModel | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218638 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1.1-statistical-method | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| entry | 0..* | Reference(EndpointAnalysisPlan) | A reference to data that supports this section | |
| section:intercurrentEventHandling | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218639 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1.2-data-handling | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:missingData | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218640 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1.3-missing-data-handling | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:sensitvityAnalysis | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218641 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1.4-sensitivity-analysis | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| entry | 0..* | Reference(EndpointAnalysisPlan) | A reference to data that supports this section | |
| section:supplementaryAnalysis | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218642 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.5.1.5-supplementary-analysis | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:exploratoryAnalysis | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s) | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218643 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s) | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.6-analysis-exploratory-objective | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:safetyAnalyses | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Safety Analyses | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218644 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.7 Safety Analyses | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.7-safety-analyses | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:otherAnalyses | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Other Analyses | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218645 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.8 Other Analyses | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.8-other-analyses | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:multiplicity | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218647 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.10 Multiplicity Adjustments | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.10-multiplicity-adjustments | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:interimAnalyses | S | 0..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Interim Analyses | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218646 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.9 Interim Analyses | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.9-interim-analyses | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| section:sampleSize | S | 1..1 | BackboneElement | Nested Section |
| title | 0..1 | string | Label for section (e.g. for ToC) Required Pattern: Sample Size Determination | |
| code | ||||
| coding | 1..1 | Coding | Code defined by a terminology system Required Pattern: At least the following | |
| system | 1..1 | uri | Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C218648 | |
| display | 1..1 | string | Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.11 Sample Size Determination | |
| text | 1..1 | string | Plain text representation of the concept Required Pattern: section10.11-sample-size-determination | |
| text | 1..1 | Narrative | Text summary of the section, for human interpretation | |
| entry | 0..* | Reference(EndpointAnalysisPlan) | A reference to data that supports this section | |
| Documentation for this format | ||||